FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
1993–2016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2025
TaperSet™ Hip System
K252846 · LPH
Shalby Advanced Technologies, Inc....
Orthopedic · 73d
Cleared Nov 20, 2025
The Response Ortho Smart Fixator - Hexapod System
K252625 · KTT
Response Ortho Solutions, LLC
Orthopedic · 93d
Cleared Nov 20, 2025
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K251904 · DPW
Remington Medical, Inc.
Cardiovascular · 153d
Cleared Nov 20, 2025
MAGNETOM Free.Max
K251822 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 160d
Cleared Nov 20, 2025
OptumSI Implant System
K251365 · OUR
Si Solutions, LLC
Orthopedic · 203d
Cleared Nov 20, 2025
PlanOne 1
K250963 · MUJ
Cosylab Jsc, Control System Laboratory
Radiology · 234d
Cleared Nov 20, 2025
Disposable Polymer Ligation Clips
K250643 · FZP
Hangzhou Kangji Medical Instrument...
General & Plastic Surgery · 261d
Cleared Nov 20, 2025
cobas liat Bordetella panel nucleic acid test
K243753 · OZZ
Roche Molecular Systems, Inc.
Microbiology · 350d
Cleared Nov 20, 2025
Nuvis® Wireless HD Camera System (Nuvis-2K)
K242606 · GCJ
Integrated Endoscopy, Inc.
General & Plastic Surgery · 447d
Cleared Nov 19, 2025
ATTUNE™ Total Knee System
K253197 · JWH
Depuy Ireland UC
Orthopedic · 54d
Cleared Nov 19, 2025
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)
K253073 · OHS
Sunglor Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 19, 2025
IPL Hair Removal Device (SYL001AZ, SYL002AZ)
K253035 · OHT
Gu'An Yeolight Smart Electronics Co.,...
General & Plastic Surgery · 58d
Cleared Nov 19, 2025
Guided Aarhus Applicator Set
K252884 · JAQ
Varian Medical Systems
Radiology · 70d
Cleared Nov 19, 2025
SternaFuse Ti Fixation System
K252661 · HRS
Fusion Innovations, LLC
Orthopedic · 89d
Cleared Nov 19, 2025
Microcurrent Facial Device (CEC101, EEI101)
K252642 · OHS
Shenzhen Dachi Communication Co., Ltd.
General & Plastic Surgery · 90d
Cleared Nov 19, 2025
Focal One®
K251910 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 152d
Cleared Nov 19, 2025
IntelliSep Test
K250912 · QUT
Cytovale, Inc.
Microbiology · 237d
Cleared Nov 19, 2025
OptiPAP Junior Flexi Tube US (OPTIPAPFUS)
K250651 · SGR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 260d
Cleared Nov 19, 2025
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
K250642 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 260d
Cleared Nov 19, 2025
MyPAO SA guides
K242603 · PBF
Medacta International S.A.
Orthopedic · 446d
Cleared Nov 18, 2025
ToeJack MIS Bunion System
K253423 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 54d
Cleared Nov 18, 2025
Miniature Telescope for Urology (27033AA)
K253411 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 49d
Cleared Nov 18, 2025
Dexcom Smart Basal
K252818 · QRX
Dexcom, Inc.
Chemistry · 75d
Cleared Nov 18, 2025
Universal Spinal System
K252729 · NKB
Double Medical Technology, Inc.
Orthopedic · 82d